Field of the Invention
The present invention relates to the catalytic protection of materials and devices that are sensitive to oxidation by integrating the catalytic protection with the material or device. The present invention particularly relates to devices designed to be implanted or inserted into the body of an animal, including humans. More particularly, the invention relates to (but is not limited to) electro-optical-based sensing devices for detecting the presence or concentration of an analyte in a medium which are characterized by being totally self-contained and of an extraordinarily compact size which permits the device to be implanted in humans for in situ detection of various analytes.
Description of Related Art
None of the references described or referred to herein are admitted to be prior art to the claimed invention.
Implantable devices for monitoring various physiological conditions are known. They include, for example, the sensors described in U.S. Pat. No. 5,517,313 to Colvin; U.S. Pat. No. 5,910,661 to Colvin; U.S. Pat. No. 5,917,605 to Colvin; U.S. Pat. No. 5,894,351 to Colvin; U.S. Pat. No. 6,304,766 to Colvin; U.S. Pat. No. 6,344,360 to Colvin et al.; U.S. Pat. No. 6,330,464 to Colvin; U.S. Pat. No. 6,400,974 to Lesho; U.S. Pat. No. 6,794,195 to Colvin; U.S. Pat. No. 7,135,342 to Colvin et al.; U.S. Pat. No. 6,940,590 to Colvin et al.; U.S. Pat. No. 6,800,451 to Daniloff et al.; U.S. Pat. No. 7,375,347 to Colvin et al.; U.S. Pat. No. 7,157,723 to Colvin et al.; U.S. Pat. No. 7,308,292 to Colvin et al.; U.S. Pat. No. 7,190,445 to Colvin et al., U.S. Pat. No. 7,553,280 to Lesho; U.S. Pat. No. 7,800,078 to Colvin, Jr. et al.; U.S. Pat. No. 7,713,745 to Colvin, Jr. et al.; U.S. Pat. No. 7,851,225 to Colvin, Jr. et al.; U.S. Pat. No. 7,939,832 to J. Colvin et al.; and in the following U.S. patent application Ser. No. 10/825,648 to Colvin et al. filed Apr. 16, 2004; Ser. No. 10/923,698 to Colvin et al. filed Aug. 24, 2004; Ser. No. 11/447,980 to Waters et al. filed Jun. 7, 2006; Ser. No. 11/487,435 to Merical et al. filed Jul. 17, 2006; Ser. No. 11/925,272 to Colvin filed Oct. 26, 2007; Ser. No. 12/508,727 to Colvin, Jr. et al. filed Jul. 24, 2009; Ser. No. 12/493,478 to Lesho filed Jun. 29, 2009; Ser. No. 12/764,389 to Colvin, Jr. et al. filed Apr. 21, 2010; Ser. No. 12/966,693 to Colvin, Jr. et al. filed Dec. 13, 2010; Ser. No. 13/103,561 to Colvin et al. filed May 9, 2011; and Ser. No. 13/171,711 to J. Colvin et al. filed Jun. 29, 2011; the contents of all of the foregoing are incorporated by reference herein. Where terms used in the current application are in conflict with use of the terms in the incorporated references, the definitions in the current application will be controlling.
When a foreign object enters a body, there is an immediate immunological response (i.e., inflammation) to eliminate or neutralize that foreign object. When the foreign object is an intentionally implanted material, device, or sensor, the inflammation response can cause damage to or otherwise negatively impact the functionality of the implant. Thus, a need exists for an implantable device (or material) that can endure the biochemical activity of an inflammation response and chronic foreign body response, i.e. oxidation, such that the efficacy and useful life of the device is not adversely impacted. A corresponding need exists for a method of manufacturing or treating an implantable device (or material) such that it can endure the biochemical activity of inflammation and foreign body response without significant loss of efficacy or useful life.
The problem of in vivo oxidation and the corresponding in vivo destruction of materials and function by reactive oxygen species (ROS) associated with inflammation response is well known. As used herein, ROS stands for reactive oxygen species, highly reactive oxygen species, or reactive oxygen radical species, and includes peroxides such as hydrogen peroxide. Some means of at least partially protecting an implanted device or material from destructive oxidation have included the use of antioxidants that may be either immobilized within or leached from an implanted device or material into the in vivo surrounding space. Systemic drugs such as anti-inflammatory varieties, superoxide dismutase mimetics, and other similar agents may also be leached or injected locally into the region around the implanted device or material in combination with, or alternatively to, antioxidants. In such cases, the device or material must either include or leach a drug or substance into the local in vivo environment and thus can become influential on wound healing, and causes the device itself to become a drug delivery mechanism in addition to its original intended purpose. Adding in the additional drug/substance release features may add complexity, variability, and uncertainty into an implant design and may complicate proving the safety and efficacy of the device or material. Also, since the inflammation response is a normal part of healing that serves to kill any bacteria that may be in the wound, drugs or leached reagents which may disable this otherwise normal aspect of wound healing might compromise the patient. Ideally, an integrated device solution which can protect just the susceptible and vulnerable component(s) of the implant would be the safest and most efficient means of solving the problem.